DPDr Shwetha Pondomatti
@drshwethapondomatti
Senior medical safety physician with 9 years' pharmacovigilance experience in aggregate reporting and signal evaluation.
IndiaWhat I'm looking for
I am a senior medical safety physician with an MD in Physiology and nine years of focused experience in pharmacovigilance. I specialize in aggregate reporting, ICSR review, signal evaluation, labelling assessment and risk management planning.
I have worked across global CRO and safety teams at IQVIA, Navitas Lifesciences, Cognizant and Qinecsa, supporting PBRER, PADER, PSUR and AdCO processes. I routinely perform selected ICSR reviews and contribute to clinical trial and post-marketing safety activities.
I maintain regulatory-compliant quality standards above 95% for aggregate and case reviews and mentor colleagues on MedDRA and LLT/IME PT coding. I have delivered training sessions and authored a thesis and presented research at national conferences.
I am committed to thorough, defensible safety assessments and collaborative signal evaluation that improve patient outcomes and regulatory confidence. I look for roles where I can apply my aggregate reporting expertise and mentor teams while advancing PV quality.
Experience
Work history, roles, and key accomplishments
Senior Medical Safety Physician
Qinecsa
Oct 2023 - Present (1 year 11 months)
Perform aggregate medical review (PBRER, PADER, PSUR, AdCO) and ICSR review for selected cases; support signal evaluation, labeling assessment and RMP activities.
IQMedical Safety Advisor
IQVIA
Jul 2016 - May 2018 (1 year 10 months)
Performed post-marketing and clinical trial ICSR review, reviewed designated medical events and trained staff on MedDRA coding and IME PT term selection.
CSAggregate Report Medical Reviewer
Cognizant Technology Solutions
Apr 2021 - Present (4 years 5 months)
Worked as aggregate medical reviewer for generic products (PBRER, PADER), maintaining quality above 95% and mentoring team members on MedDRA coding and signal evaluation.
Senior Medical Reviewer
Navitas Lifesciences
May 2018 - Present (7 years 4 months)
Served as safety physician for post-marketing ICSR and clinical trial PV, medical-reviewed PBRERs and PADERs, and mentored MedDRA coding with consistent regulatory compliance and quality above 95%.
General Physician Consultant
Medall Clumax Diagnostic Centre
Apr 2015 - Present (10 years 5 months)
Provided general medical consultation and diagnostic assessments at AECS Layout branch, managing patient care and clinical documentation.
Education
Degrees, certifications, and relevant coursework
JJM Medical College, Davangere
Doctor of Medicine, Physiology
2009 - 2013
Activities and societies: Thesis: Comparative study of Physical Fitness Index between residential and non-residential school children of Davangere; poster presentation on anemia in pregnancy (APPICON 2011) and paper presentation (Vishakapatnam 2012).
Completed MD in Physiology at JJM Medical College, Davangere in 2013 with a thesis on comparative physical fitness index.
JJM Medical College, Davangere
Bachelor of Medicine, Bachelor of Surgery, Medicine
2003 - 2009
Completed MBBS (Bachelor of Medicine, Bachelor of Surgery) at JJM Medical College, Davangere in 2009.
Deshishiya Higher Secondary Vidyashaala
Higher Secondary Education, Science
Completed higher secondary education at Deshishiya Higher Secondary Vidyashaala in 2003.
Swamy Vivekananda English High School, Shimoga
Secondary Education, Science
1990 - 2001
Completed secondary schooling at Swamy Vivekananda English High School, Shimoga in 2001.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
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